To define the recommended Phase II dose of hCBE-11 [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ICMJE (submitted: June 23, 2005)

To define the recommended Phase II dose of hCBE-11

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Safety and Tolerability of hCBE-11 in Subjects With Advanced Solid Tumors

Official Title ICMJE

A Phase I, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of hCBE-11, a Humanized Monoclonal Antibody, in Subjects With Advanced Solid Tumors

Brief Summary

This is a Phase I, open-label, dose-escalation study on subjects with advanced solid tumors. This is the first study of hCBE-11 in humans and is designed to determine the safety and how well patients tolerate this investigational drug. The study duration is two years with treatment visits occurring weekly for either 4 or 8 weeks, follow-up for 8 weeks and long-term follow-up contact every 3 months thereafter.